New Rules On Consent Urged For Transplants

March 10, 1985|By Michael L. Millenson, Chicago Tribune.

NEW ORLEANS — The chairman of the Humana Heart Institute International said Saturday that his group plans to press for permission to change the procedure governing consent forms signed by patients receiving an artificial heart so that more of them will be eligible for the potentially life-saving technology.

Dr. Allan M. Lansing, founder of the Louisville-based institute and chief clinical spokesman for the artificial heart program, also acknowledged that the mechanical device may prove too expensive to ever become widely used.

``It`s a possibility that the technology may be too expensive for anybody to afford. It`s like anything else in life--automobiles or yachts,`` Lansing told reporters after he gave a speech here to the Federation of American Hospitals, the trade group representing investor-owned hospitals.

Lansing criticized the complexity of the 16-page consent form and its requirements that a patient sign it, then wait 24 hours and sign it again.

He said the form prevents some severely ill people from receiving artificial hearts. In particular, Lansing singled out those rushed to the hospital in shock after a heart attack and those who must rely on special machines after surgery.

``A patient deeply ill and in shock from a myocardial infarction (heart attack) may be semiconscious. These people cannot sign this consent form and they cannot wait another 24 hours for it,`` Lansing said, adding that such conditions are common.

Lansing said that Dr. William DeVries, the hospital`s chief surgeon for the artificial heart, will ask the institute`s review board to change the form. After that, the institute must get permission from the Food and Drug Administration to use a new form with patients. The artificial heart research is classified as an experimental program, and as such is subject to government review.

Lansing also defended last week`s decision of a surgeon in Arizona to implant an unapproved artificial heart, different from the one used at the institute, without waiting for government consent. ``This was absolutely the thing to do if you have the facilities available, whether it`s a Jarvik-7 heart or not. A human life is at stake.``

Lansing said that an increasing shortage of human hearts for transplantation make development of a mechanical model more urgent. ``We`re going to have to go the way of Loma Linda--animal donors--or find mechanical hearts or give up altogether.